Perioperative Intravesical Instilation of Hypertonic Saline Following Bladder
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events as assessed by Common Terminology Criteriafor Adverse Events of Renal and urinary disorders (CTCAE)Version 5.0,2017, Satisfaction assessed by Clavien-Dindo.
研究概览
简要总结
Hypertonic saline at the concentration of 3% (hypersel) has been injected for years into echinococcal cysts to kill live scolices, and is also known to kill suspended cells by means of a steep osmotic gradient and the investigators postulate that perioperative intravesical instillation of hypersel for patients with low grade bladder cancer is safe and may be active against shedded and suspended tumor cells and thus may decrease recurrence risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of 18 years or older able to sign informed consent
- •A previous diagnosis of low grade bladder cancer
- •A pyelographic imaging examination (CTU, MRU, IVP, antegrade/retrograde pyelography) showing normal upper urinary tract in the 12 months prior to inclusion
- •Serum creatinine levels ≤ 2.0 mg/dl
- •Serum sodium levels <146 mg/ml
- •Current bladder tumor diagnosed by endoscopy or imaging in the last 3 months
- •Patient is candidate for TURBT
排除标准
- •Previous history of high grade bladder cancer including carcinoma in situ
- •Presence of upper urinary tract tumor on imaging
- •Renal failure with serum creatinine >2.0 mg/dl prior to inclusion
- •Hypernatremia >146 mg/dl prior to inclusion
- •Contra-indication to undergo TURBT
研究组 & 干预措施
Patient with low grade TCC
- Patients of 18 years or older able to sign informed consent
- A previous diagnosis of low grade bladder cancer
- A pyelographic imaging examination (CTU, MRU, IVP, antegrade/retrograde pyelography) showing normal upper urinary tract in the 12 months prior to inclusion
- Serum creatinine levels ≤ 2.0 mg/dl
- Serum sodium levels <146 mg/ml
- Current bladder tumor diagnosed by endoscopy or imaging in the last 3 months
- Patient is candidate for TURBT
干预措施: Hypertonic Saline 3% (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events as assessed by Common Terminology Criteriafor Adverse Events of Renal and urinary disorders (CTCAE)Version 5.0,2017, Satisfaction assessed by Clavien-Dindo.
时间窗: 12 month
The investigators monitored the Sodium levels in the blood after the administration of the Hypertonic Saline and documented and measure side effects by Clavien-Dindo scale
次要结局
未报告次要终点
研究者
Dan Leibovici
Professor Dan Leibovici- Head of the Urology department of Kaplan MC
Kaplan Medical Center